MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-28 for PORTEX? ULTRAPERC? SINGLE STAGE DILATOR TECHNIQUE KITS 30/08 manufactured by Smiths Medical Asd; Inc..
[122169612]
Report source: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[122169613]
Information was received indicating that the dilator to a smiths medical portex? Ultraperc? Single stage dilator technique kit became bent while being used on a patient. A second kit was used to complete the tracheostomy procedure. There were no reported adverse effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2018-03909 |
| MDR Report Key | 7918077 |
| Date Received | 2018-09-28 |
| Date of Report | 2018-09-27 |
| Date of Event | 2018-08-30 |
| Date Mfgr Received | 2018-08-30 |
| Date Added to Maude | 2018-09-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DAVE HALVERSON |
| Manufacturer Street | 6000 NATHAN LANE N |
| Manufacturer City | MINNEAPOLIS, MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833310 |
| Manufacturer G1 | SMITHS MEDICAL INTERNATIONAL LTD. |
| Manufacturer Street | BOUNDARY ROAD |
| Manufacturer City | HYTHE, KENT CT216JL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CT21 6JL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PORTEX? ULTRAPERC? SINGLE STAGE DILATOR TECHNIQUE KITS |
| Generic Name | DILATOR, TRACHEAL |
| Product Code | KCG |
| Date Received | 2018-09-28 |
| Catalog Number | 30/08 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD; INC. |
| Manufacturer Address | 6000 NATHAN LANE N MINNEAPOLIS, MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-28 |